FDA.reportPublic FDA data

Dermaharmony Pyrithione Zinc

Manufacturer
D3 Development, Inc. | Vanguard Soap, LLC.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:47:58

Label at a glance#

ProductDermaharmony Pyrithione Zinc with Shea Butter
Active ingredientPYRITHIONE ZINC
Label structure11 sections

Storage and handling

Other information Store at room temperature Lot number and expiration date are printed on back panel.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Pyrithione zinc 2%

OTC - PURPOSE SECTION

Purpose

Dandruff, Seborrheic dermatitis soap

INDICATIONS & USAGE SECTION

Uses

Controls and reduces the symptoms of dandruff and seborrheic dermatitis.

WARNINGS SECTION

Warnings

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you havea condition that covers a large area of the body.

OTC - WHEN USING SECTION

When using this productavoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor ifcondition worsens or does not improve after regular use as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Use on affected areas in place of your regular soap
  • For best results use at least twice a week or as directed by a doctor
  • Work up a lather using warm water and massage into affected areas
  • Rinse well

STORAGE AND HANDLING SECTION

Other information

  • Store at room temperature
  • Lot number and expiration date are printed on back panel.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Sodium palmate, shea butter, sodium cocoate*, sodium palm kernelate*, glycerin, water, cocoa butter, titanium dioxide, Avena Sativa (oat) kernel flour, tetrasodium glutamate diacetate, tocopheryl acetate (vitamin E), Rosmarinus officinalis (rosemary) leaf extract. *May contain this ingredient

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in the USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermaharmony

2% Pyrithione Zinc SOAP with Shea Butter

For Seborrheic Dermatitis & Dandruff

NET WT 3.7 OZ (105 G)

71819-017 PZ with Shea Butter71819-017 PZ with Shea Butter

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244458zinc pyrithione 2 % Medicated ShampooPSN2
244458zinc pyrithione 20 MG/ML Medicated ShampooSCD2
244458zinc pyrithione 2 % Medicated ShampooSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-017-37Dermaharmony Pyrithione Zincwith Shea Butter105 g in 1 PACKAGESOAP1052

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71819-017DERMAHARMONY PYRITHIONE ZINC WITH SHEA BUTTER (PYRITHIONE ZINC) SOAP [D3 DEVELOPMENT, INC.]2Current NDC, Legacy NDC, 1 package rows20241222_dc7ba02c-bdbd-5136-e053-2995a90ac545.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71819-01771819-017-37

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHEA BUTTERK49155WL9YIACT
COCOA BUTTER512OYT1CRRIACT
SODIUM CHLORIDE451W47IQ8XIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
SODIUM COCOATER1TQH25F4IIACT
GLYCERINPDC6A3C0OXIACT
OATMEAL8PI54V663YIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
SODIUM PALMATES0A6004K3ZIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
ROSEMARYIJ67X351P9IACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaharmony Pyrithione Zinc with Shea ButterPYRITHIONE ZINCD3 Development, Inc.dc7ba02c-bdbd-5136-e053-2995a90ac5452024-12-20WarningsExact identifier
ndc (package): 71819-017-37
ndc (product): 71819-017
ndc11 (package): 71819001737
spl id: 29bad11f-2f7e-9b3d-e063-6394a90a4f86
spl set id: dc7ba02c-bdbd-5136-e053-2995a90ac545

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.